Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213072
Company: ALTHERA PHARMS

Products on NDA 213072

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 5MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 10MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 20MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 40MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213072

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2021	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213072s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213072Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213072Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2024	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213072s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213072Orig1s004ltr.pdf

Labels for NDA 213072

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2024	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213072s004lbl.pdf
03/23/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213072s000lbl.pdf